FDA 510(k) Application Details - K971423

Device Classification Name	Vinyl Patient Examination Glove   More FDA Info for this Device
510(K) Number	K971423
Device Name	Vinyl Patient Examination Glove
Applicant	SHANGHAI FOREMOST PLASTIC INDUSTRIAL CO., LTD. YAN LIN ROVER BRIDGE EAST CHE XING HWY. CHE DUN TOWN SONGJIANG COUNTY, SHANGHAI 201611 CN Other 510(k) Applications for this Company
Contact	TIANG S CHANG Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LYZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/17/1997
Decision Date	05/23/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review